483 Roundup: FDA Finds Shortfalls at Four Device Facilities
The FDA found numerous GMP and other violations during inspections of four device manufacturing facilities.
Audina Hearing Instrument: Audina Hearing Instrument of Longwood, Florida drew the FDA’s attention for various deficiencies observed during a May inspection, including inadequate procedures for responding to problems and complaints.
The agency said the company, Audina Hearing Instrument, of Longwood, did not include verification requirements to ensure corrective actions were effective in responding to problems and did not designate a specific unit in the company to handle complaints.
The agency also observed hearing-aid components stored in open anti-static bags, and employees working in an assembly area without wearing the wrist straps required by the company’s written instructions.
Intra-Lock International: The FDA cited a Florida manufacturer of dental implants for numerous GMP and other deficiencies uncovered in a spring inspection.
The inspection of the Intra-Lock International facility in Boca Raton revealed problems with complaint evaluations, product standards, corrective actions, design changes, and assuring supplies received by the company were up to snuff.
The FDA pointed to the firm’s failure to thoroughly follow up on a report from a member of its sales team that a wrong screw had been included in the packaging for one product.
The agency also observed a problem with package sealing, and the firm’s failure to document and validate a change in cap size adopted in response to the issue.
Marlen: The FDA cited Marlen Manufacturing & Development for unclear CAPA procedures and inadequate complaint handling.
The agency issued a Form 483 to the devicemaker following a March inspection of its Bedford, Ohio, facility. Investigators found the facility’s CAPA procedure was incomplete. For example, it did not clearly specify when a CAPA is required, and did not establish what documentation is required for a preventive action. The procedure also failed to does not address verification/validation, effectiveness activities or actions needed to close a CAPA, the agency said.
The inspection further found that the facility complaint procedure does not explain how complaints are received, documented or assessed, or how the company documents why an investigation is not required. It also does not address the requirement to review and document complaints to determine whether an MDR is necessary.
The FDA also found the company’s procedures for nonconformance controls does not detail how to document incoming and in-process non-conformances and when an investigation is necessary. Procedures for purchasing are also incomplete, with no documentation indicating the company is monitoring its 29 active suppliers.
Furthermore, the company has not incorporated the UDI labeling process, nor does its process control procedure define calibration activities or requirements. The company promised to correct all six observations.
ADProducts: The FDA cited ADProducts for problems with its complaints, MDRs and contractor agreements.
Following a June inspection of the devicemaker’s Spokane, Wash., facility, the agency issued a Form 483. According to investigators, the company did not define or implement complaint handling procedures. ADProducts documented one complaint for its AD Mirror System. The 2016 complaint did not document an evaluation for Medical Device Reporting, and a second complaint described to investigators was not documented.
The company also had not defined or documented procedures covering MDR or finished device acceptance. The firm had no agreement with its contractors to notify ADProducts of changes in the product or service, and had no procedures governing the requirements for contract manufacturers.
The facility also lacked procedures for CAPA, quality audits or document control.
Read the Audina Form 483 here: www.fdanews.com/08-08-17-audinahearinginstrument483.pdf.
Read the Intra-Lock Form 483 here: www.fdanews.com/08-08-17-intralockinternational483.pdf.
Read the Marlen Form 483 here: www.fdanews.com/08-10-17-marlenmanudevelopco483.pdf.
Read the ADProducts Form 483 here: www.fdanews.com/08-10-17-adproductsllc483.pdf. — Zack Budryk and Gregory Roberts